Title: Recombinant Plague Vaccine rF1V in Healthy Volunteers

Summary

This Phase 2(a) clinical trial is designed as a dose-blinded, block-randomized, multi-center study to select a dosage and schedule of rF1V vaccine for further studies based on the immune response up to Day 210. Additional immunogenicity and safety/reactogenicity data will be collected through Day 540. Selection of dosage and schedule will be based on GMCs and seroconversion rates for anti-F1, anti-V and anti-rF1V antibody titers. Approximately 400 healthy adult volunteers will be enrolled (100 per group) in this study.

Conditions

• Healthy Volunteers

Interventions

BIOLOGICAL

rFIV vaccine

rF1V vaccine 80 mcg given by intramuscular (IM) injection into the arm on study Days 0, 28, 182

BIOLOGICAL

rF1V vaccine

rF1V 80 mcg vaccine given by intramuscular (IM) injection into the arm on study Days 0, 56, 182

BIOLOGICAL

rF1V vaccine

rF1V 160 mcg vaccine given by intramuscular (IM) injection into the arm on Study Days 0, 28, 182

BIOLOGICAL

rF1V vaccine 160 mcg given on Study Days 0, 56, 182

rF1V 160 mcg vaccine given by Intramuscular (IM) injection into the arm on Study days 0. 56, 182

Sponsors & Collaborators

• DynPort Vaccine Company LLC, A GDIT Company

  lead INDUSTRY

Principal Investigators

• Ivor Emmanual, MD · Benchmark Research

• Steven Folkerth, MD · Clinical Research Center of Neveda

• Richard Greenberg, MD · University of Kentucky - Department of Infectious Disease

• Vicki Grieff, MD · Alta Clinical Research, LLC

• John Jacobsen, MD · Meridian Clinical Research, LLC

• Keith Reisinger, MD · Primary Physicians Research, Inc.

• George Risi, MD · Infectious Disease Specialists, PC

• L. Tyler Wadsworth, MD · Sundance Clinical Research

• Iaasc Marcadis, MD · Palm Beach Research

Study Design

Allocation

RANDOMIZED

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

55 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2006-05-31

Primary Completion

2008-02-29

Completion

2008-10-31

Countries

• United States

Study Locations